WHO IS NUTROPIN THERAPY FOR?

Nutropin AQ® [somatropin (rDNA origin) injection]
is human growth hormone that is available by prescription
only.

Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they:

Do not make enough growth hormone on their own

Have idiopathic short stature, which means they are shorter than 98.8% of other children of the same age and sex; are growing at a rate not likely to allow them to reach normal adult height; and no other cause of short stature can be found

Have Turner syndrome

Have chronic kidney disease (CKD) up to the time of kidney transplant

Doctors prescribe Nutropin therapy for adults who have growth hormone deficiency that began either in:

Adulthood as a result of pituitary disease, diseases of the hypothalamus, surgery, radiation therapy, or trauma; or

Childhood. Patients treated for growth hormone deficiency in childhood, whose bones have stopped growing, should be reevaluated to see if they need to continue with growth hormone therapy

Your doctor will test to see if growth hormone is right for
you.

IMPORTANT SAFETY INFORMATION

Nutropin therapy and your safety:

Please read this important safety information
carefully. Then, if you have any questions, talk with your doctor.

NUTROPIN THERAPY IS NOT FOR:

Patients having serious complications after undergoing open heart
surgery, abdominal surgery, serious injuries involving many body
systems, or life-threatening breathing problems. Deaths have been
reported in such cases

Children who have Prader-Willi syndrome (PWS) and are very
overweight or have a history of severe breathing problems. Deaths have
been reported in children with PWS who are very overweight, have a
history of blocked upper airways, sleep apnea (pauses in breathing
during sleeping), or other severe breathing problems

Patients who have active cancer. Because growth hormone deficiency
can be an early sign of some tumors in the brain or pituitary gland,
the presence of these types of tumors should be ruled out by your
doctor before you start Nutropin therapy

Adults or children with certain types of eye disease caused by
diabetes

Children and teenagers whose bones have finished growing

Patients who are allergic to somatropin, the active ingredient in
Nutropin therapy. Reactions at the injection site are the most common
allergic reactions

What should you tell your doctor before starting Nutropin
therapy?

If you take cyclosporine, hormone replacement therapy, insulin or
other diabetes medications, drugs containing steroids, or drugs for
seizures. These medications may need to be adjusted during Nutropin
therapy

If you had cancer as a child. An increased risk of a new tumor,
particularly certain brain tumors, has been reported in patients taking
Nutropin therapy. If you have pre-existing tumors or growth hormone
deficiency caused by abnormal tissue in the brain, you should be
watched closely for the worsening or return of this condition

If you have diabetes, risk factors for diabetes, or impaired
glucose tolerance. If so, your doctor should monitor your blood sugar
closely during Nutropin therapy. New cases of type 2 diabetes have been
reported in patients taking Nutropin therapy

If you have hypopituitarism (an inability of the pituitary gland to
produce sufficient hormones) and are on standard hormone replacement
therapy. In that case, your doctor should monitor your hormone
replacement therapy closely while you are taking Nutropin therapy

If you are pregnant, nursing, or plan to become pregnant. It is not
known whether Nutropin is excreted in human milk. Nutropin therapy
should be used during pregnancy only when clearly needed

While taking Nutropin, contact your doctor immediately if you
experience:

Changes in vision, a bad headache, or nausea with or without
vomiting. This may be a sign of increased pressure in the brain

A limp or have hip or knee pain

A fracture in the ball of the hip joint can occur in
children who have endocrine problems and in children who have
rapid growth

Children with growth failure due to CKD should be examined
periodically for evidence of loss of bone minerals. Hip x-rays
should be taken before starting Nutropin therapy in these
children

Progression of scoliosis (curvature of the spine) that can occur in
children who have rapid growth. Nutropin therapy has not been shown to
increase the occurrence of this condition

Any allergic reaction you experience to the injection of Nutropin
therapy

Abdominal pain. Cases of pancreatitis (inflammation of the
pancreas) have been reported rarely in children and adults receiving
Nutropin therapy

Other important information about Nutropin

Adults may retain water during Nutropin therapy. This may be brief
but may increase with higher doses of Nutropin therapy

Patients should have their thyroid function tested periodically
during Nutropin therapy. Thyroid hormone treatment may need to be
started or adjusted

Patients should be sure to inject Nutropin at a different
recommended place on their body each time to avoid tissue breakdown. A
doctor or nurse should provide injection training and supervise the
first injection

The use of Nutropin therapy has not been studied in patients over
65 years of age. Elderly patients may be more sensitive to Nutropin
therapy and may experience more side effects

Patients with Turner syndrome should be monitored closely by a
doctor for ear infections and cardiovascular problems during Nutropin
therapy

Nutropin therapy may affect the body’s ability to process two
hormones, cortisol and cortisone, which can lead to a condition called
hypoadrenalism (under activity of the adrenal gland). In that case,
glucocorticoid replacement therapy may need to be prescribed

What are common possible side effects of Nutropin
therapy?

Common side effects reported in adults and children taking Nutropin
therapy include injection site reactions. Additional common side effects in
adults include swelling, joint pain, and carpal tunnel syndrome.

You may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects
to Genentech at (888) 835-2555.

How should you store Nutropin?

Nutropin must be kept refrigerated (36° to 46°F [2° to 8°C]). Do
not freeze. Cartridges and NuSpin pens must be used within 28 days
of initial use. Throw away any unused Nutropin after 28 days of initial
use. Before giving an injection, check the manufacturer's expiration date
on the cartridge or pen. Do not use if it has expired. Do not inject
medication if the solution is cloudy.

Your healthcare team is your first source of information about your therapy.

Video Library

Meet Sebastian

Hear Sebastian’s story of his diagnosis of growth hormone deficiency, learning to use the NuSpin injection device, and his experience with Nutropin therapy.

Working with GPS: Andrea's Experience

A mother’s story of learning about therapy options for her son, using Nutropin GPS and the co-pay program, and describing how NuSpin fits in their daily routine.

How to Use NuSpin for Injections

Sebastian, a Nutropin patient, and his mom Andrea, walk through the steps associated with using the NuSpin device for Nutropin therapy.

WHO IS NUTROPIN THERAPY FOR?

Nutropin AQ® [somatropin (rDNA origin) injection]
is human growth hormone that is available by prescription
only.

Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they:

Do not make enough growth hormone on their own

Have idiopathic short stature, which means they are shorter than 98.8% of other children of the same age and sex; are growing at a rate not likely to allow them to reach normal adult height; and no other cause of short stature can be found

Have Turner syndrome

Have chronic kidney disease (CKD) up to the time of kidney transplant

Doctors prescribe Nutropin therapy for adults who have growth hormone deficiency that began either in:

Adulthood as a result of pituitary disease, diseases of the hypothalamus, surgery, radiation therapy, or trauma; or

Childhood. Patients treated for growth hormone deficiency in childhood, whose bones have stopped growing, should be reevaluated to see if they need to continue with growth hormone therapy

Your doctor will test to see if growth hormone is right for
you.

IMPORTANT SAFETY INFORMATION

Nutropin therapy and your safety:

Please read this important safety information
carefully. Then, if you have any questions, talk with your doctor.

NUTROPIN THERAPY IS NOT FOR:

Patients having serious complications after undergoing open heart
surgery, abdominal surgery, serious injuries involving many body
systems, or life-threatening breathing problems. Deaths have been
reported in such cases

Children who have Prader-Willi syndrome (PWS) and are very
overweight or have a history of severe breathing problems. Deaths have
been reported in children with PWS who are very overweight, have a
history of blocked upper airways, sleep apnea (pauses in breathing
during sleeping), or other severe breathing problems

Patients who have active cancer. Because growth hormone deficiency
can be an early sign of some tumors in the brain or pituitary gland,
the presence of these types of tumors should be ruled out by your
doctor before you start Nutropin therapy

Adults or children with certain types of eye disease caused by
diabetes

Children and teenagers whose bones have finished growing

Patients who are allergic to somatropin, the active ingredient in
Nutropin therapy. Reactions at the injection site are the most common
allergic reactions

What should you tell your doctor before starting Nutropin
therapy?

If you take cyclosporine, hormone replacement therapy, insulin or
other diabetes medications, drugs containing steroids, or drugs for
seizures. These medications may need to be adjusted during Nutropin
therapy

If you had cancer as a child. An increased risk of a new tumor,
particularly certain brain tumors, has been reported in patients taking
Nutropin therapy. If you have pre-existing tumors or growth hormone
deficiency caused by abnormal tissue in the brain, you should be
watched closely for the worsening or return of this condition

If you have diabetes, risk factors for diabetes, or impaired
glucose tolerance. If so, your doctor should monitor your blood sugar
closely during Nutropin therapy. New cases of type 2 diabetes have been
reported in patients taking Nutropin therapy

If you have hypopituitarism (an inability of the pituitary gland to
produce sufficient hormones) and are on standard hormone replacement
therapy. In that case, your doctor should monitor your hormone
replacement therapy closely while you are taking Nutropin therapy

If you are pregnant, nursing, or plan to become pregnant. It is not
known whether Nutropin is excreted in human milk. Nutropin therapy
should be used during pregnancy only when clearly needed

While taking Nutropin, contact your doctor immediately if you
experience:

Changes in vision, a bad headache, or nausea with or without
vomiting. This may be a sign of increased pressure in the brain

A limp or have hip or knee pain

A fracture in the ball of the hip joint can occur in
children who have endocrine problems and in children who have
rapid growth

Children with growth failure due to CKD should be examined
periodically for evidence of loss of bone minerals. Hip x-rays
should be taken before starting Nutropin therapy in these
children

Progression of scoliosis (curvature of the spine) that can occur in
children who have rapid growth. Nutropin therapy has not been shown to
increase the occurrence of this condition

Any allergic reaction you experience to the injection of Nutropin
therapy

Abdominal pain. Cases of pancreatitis (inflammation of the
pancreas) have been reported rarely in children and adults receiving
Nutropin therapy

Other important information about Nutropin

Adults may retain water during Nutropin therapy. This may be brief
but may increase with higher doses of Nutropin therapy

Patients should have their thyroid function tested periodically
during Nutropin therapy. Thyroid hormone treatment may need to be
started or adjusted

Patients should be sure to inject Nutropin at a different
recommended place on their body each time to avoid tissue breakdown. A
doctor or nurse should provide injection training and supervise the
first injection

The use of Nutropin therapy has not been studied in patients over
65 years of age. Elderly patients may be more sensitive to Nutropin
therapy and may experience more side effects

Patients with Turner syndrome should be monitored closely by a
doctor for ear infections and cardiovascular problems during Nutropin
therapy

Nutropin therapy may affect the body’s ability to process two
hormones, cortisol and cortisone, which can lead to a condition called
hypoadrenalism (under activity of the adrenal gland). In that case,
glucocorticoid replacement therapy may need to be prescribed

What are common possible side effects of Nutropin
therapy?

Common side effects reported in adults and children taking Nutropin
therapy include injection site reactions. Additional common side effects in
adults include swelling, joint pain, and carpal tunnel syndrome.

You may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects
to Genentech at (888) 835-2555.

How should you store Nutropin?

Nutropin must be kept refrigerated (36° to 46°F [2° to 8°C]). Do
not freeze. Cartridges and NuSpin pens must be used within 28 days
of initial use. Throw away any unused Nutropin after 28 days of initial
use. Before giving an injection, check the manufacturer's expiration date
on the cartridge or pen. Do not use if it has expired. Do not inject
medication if the solution is cloudy.

Your healthcare team is your first source of information about your
therapy.